Adverse Events Reports Soar

The number of individuals who report negative side effects from taking prescription drugs has soared in the past decade, and now almost equals the number of adverse events turned in by physicians and pharmacists, according to newly released statistics from the Food and Drug Administration.

In 2003, the year before the Vioxx scandal broke, there were just under 50,000 such reports from consumers, about what it had been for the previous four years. But by 2007 that number had more than tripled to 174,206 adverse event reports. Over the same period, reports from providers rose 42 percent to 202,686 reports.

It is well-known that the FDA's adverse events monitoring system misses most unwanted and dangerous side effects because it relies on self-reporting by physicians and consumers/patients. That's why Congress last year voted more money to beef up the nation's post-market surveillance system. The FDA is currently hiring new biostatisticians to conduct epidemiological analyses of insurers' databases of patient outcomes like the one done by David Graham that proved just how dangerous Vioxx was.

But even when those new employees are in place, adverse events reporting by individuals, physicians and pharmacists will remain an important part of the system. Such reports alert regulators to the possibility that something may be wrong with a drug that was never noticed or was too rare to be picked up in the original clinical trials that led to the drug's approval. They are the clues that tell the biostatisticians where to look.

What these data clearly show is just how important consumer awareness is in generating those reports. The Vioxx headlines are fading. To help keep consumers vigilant, the FDA should move rapidly to put a prominent warning label on every drug container and package. It should state that the drug may cause unwanted and as yet unidentified side effects, and it should provide a 24-hour 800 number to call should such events occur. A similar warning should be contained on every direct-to-consumer print and broadcast ad.

Such labels cost manufacturers nothing. But they will generate additional anecdotal evidence that could help regulators identify the hidden dangers in some prescription drugs.